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the FDA of a review letter related to its pending New Drug Application (NDA) for Acurox (oxycodone +
niacin) tablets. On 2/22/09, Acurox was granted a priority review classification by the FDA with a PDUFA
action date of 6/30/09. FDA stated in the review letter that their comments are preliminary, subject to
change, and do not reflect a final decision on the information reviewed or a review of the entire NDA.
Based on the review letter, ACUR does not believe Acurox will receive NDA approval on the PDUFA date.
ACUR has an exclusive licensing agreement with King Pharma (NYSE:KG) for the development and
commercialization of certain opioid analgesic products utilizing the Company's Aversion Technology, which
includes an exclusive license for Acurox.
Javelin Pharma (AMEX:JAV): On 6/23/09, JAV reported that it has completed its open-label multi-dose,
multi-day, observational safety study of Dyloject in the U.S. and that the study successfully met its
objective. The objective of the study was to evaluate the safety of Dyloject following IV bolus administration
of multiple doses over multiple days in patients aged 18 to 85 with acute post-operative pain. 856 patients
successfully completed the study, receiving at least 8 doses of Dyloject over a 48 hour period.
The successful completion of this study satisfies the Company's goal of having well in excess of a
1000-patient safety data base for its Dyloject NDA filing with the FDA, which is planned for the fall of 2009
at the same 37.5 mg dose used in the study. Dyloject is an injectable formulation of diclofenac in Phase 3
clinical development in the U.S. and already marketed in the U.K. In December 2008, JAV released top-line
results from its second of two Dyloject pivotal Phase 3 clinical trials, which demonstrated effectiveness
across all five primary study endpoints.
Boston Scientific (NYSE:BSX): On 6/23/09, BSX announced that the landmark MADIT-CRT trial has met
its primary endpoint. Preliminary results show the Company's cardiac resynchronization therapy
defibrillators (CRT-Ds) to be associated with a significant 29% reduction (p=0.003) in death or heart
failure interventions when compared to traditional implantable cardioverter defibrillators (ICDs).
MADIT-CRT demonstrates that early intervention with cardiac resynchronization therapy can slow the
progression of heart failure. It is the world's largest randomized NYHA Class I/II CRT-D trial, with more than
1,800 patients enrolled at 110 centers in 14 countries. The trial is being conducted under the leadership
of Principal Investigator Arthur J. Moss, M.D., Professor of Medicine at the University of Rochester Medical
Center.
Disclosure: No positions.
Original Article
niacin) tablets. On 2/22/09, Acurox was granted a priority review classification by the FDA with a PDUFA
action date of 6/30/09. FDA stated in the review letter that their comments are preliminary, subject to
change, and do not reflect a final decision on the information reviewed or a review of the entire NDA.
Based on the review letter, ACUR does not believe Acurox will receive NDA approval on the PDUFA date.
ACUR has an exclusive licensing agreement with King Pharma (NYSE:KG) for the development and
commercialization of certain opioid analgesic products utilizing the Company's Aversion Technology, which
includes an exclusive license for Acurox.
Javelin Pharma (AMEX:JAV): On 6/23/09, JAV reported that it has completed its open-label multi-dose,
multi-day, observational safety study of Dyloject in the U.S. and that the study successfully met its
objective. The objective of the study was to evaluate the safety of Dyloject following IV bolus administration
of multiple doses over multiple days in patients aged 18 to 85 with acute post-operative pain. 856 patients
successfully completed the study, receiving at least 8 doses of Dyloject over a 48 hour period.
The successful completion of this study satisfies the Company's goal of having well in excess of a
1000-patient safety data base for its Dyloject NDA filing with the FDA, which is planned for the fall of 2009
at the same 37.5 mg dose used in the study. Dyloject is an injectable formulation of diclofenac in Phase 3
clinical development in the U.S. and already marketed in the U.K. In December 2008, JAV released top-line
results from its second of two Dyloject pivotal Phase 3 clinical trials, which demonstrated effectiveness
across all five primary study endpoints.
Boston Scientific (NYSE:BSX): On 6/23/09, BSX announced that the landmark MADIT-CRT trial has met
its primary endpoint. Preliminary results show the Company's cardiac resynchronization therapy
defibrillators (CRT-Ds) to be associated with a significant 29% reduction (p=0.003) in death or heart
failure interventions when compared to traditional implantable cardioverter defibrillators (ICDs).
MADIT-CRT demonstrates that early intervention with cardiac resynchronization therapy can slow the
progression of heart failure. It is the world's largest randomized NYHA Class I/II CRT-D trial, with more than
1,800 patients enrolled at 110 centers in 14 countries. The trial is being conducted under the leadership
of Principal Investigator Arthur J. Moss, M.D., Professor of Medicine at the University of Rochester Medical
Center.
Disclosure: No positions.
Original Article
| FDA Updates on Acura Pharma, Boston Scientific, and Javelin Pharma by BioMedReports.com, June 23, 2009 |
Below is a summary of updates to the BioMedReports.com FDA Calendar, which
includes a database of over 200 entries. The calendar was originally created by
Mike Havrilla to track companies with pending new drug, biological agent, or
medical device new product decisions at the FDA. With the launch of
BioMedReports.com, the FDA Calendar has expanded to include the following
categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA,
sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to
the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are
designed to support a filing for FDA approval.
Acura Pharma (NASDAQ:ACUR): On 6/23/09, ACUR announced the receipt from
includes a database of over 200 entries. The calendar was originally created by
Mike Havrilla to track companies with pending new drug, biological agent, or
medical device new product decisions at the FDA. With the launch of
BioMedReports.com, the FDA Calendar has expanded to include the following
categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA,
sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to
the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are
designed to support a filing for FDA approval.
Acura Pharma (NASDAQ:ACUR): On 6/23/09, ACUR announced the receipt from
| BioMedReports.com is an informational website that focuses on healthcare and biomedical stocks. BioMedReport's Bio Visit the website at BioMedReports,com. |
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